Expired Study
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New York, New York 10021


Purpose:

This is an open label, Phase I study of vaccination with NY-ESO-1 OLP4 with or without immunoadjuvant Montanide and Poly-ICLC in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission. The primary and secondary endpoints of the study are to determine the safety and immunogenicity of NY-ESO-1 OLP4 vaccination with or without immunoadjuvants Montanide and Poly-ICLC.


Study summary:

Cohort I (n=3) will receive NY-ESO-1 OLP4 by subcutaneous injection once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16 patients will return for final toxicity and immunologic assessments. If 0/3 DLT's are seen in Cohort I, this arm will be considered safe and accrual for this arm will stop. If 1/3 patients experience a DLT (as defined in section 11), then 3 further patients will be accrued. If 1/6 experience a DLT this arm will be considered safe. If >1/6 patients in this arm experience a DLT then this arm will not be considered safe, and accrual for the study will stop. If this arm is considered safe we will proceed to Cohort II. Cohort II (n=3 + 6) will receive NY-ESO-1 OLP in combination with Montanide immune adjuvant by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16 patients will return for final toxicity and immunologic assessments. If 0/3 initial patients experience a DLT we will add 6 further patients to this arm at the same dose and schedule described above, for a total of 9 patients. If 1/3 patients have a DLT, we will accrue 3 further patients at this dose and schedule. If 1/6 have a DLT this arm will be considered safe, and 3 further patients will be tested. Cohort III will begin accrual after 6 patients in cohort II have received all 5 vaccinations with no more than one DLT observed (this criterion has already been met in the study). Cohort III (n=3 + 6) will receive NY-ESO-1 OLP mixed with Poly-ICLC immunoadjuvant emulsified in Montanide by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. At week 16, patients will return for final toxicity and immunologic assessments. If 0/3 initial patients in Cohort III experience a DLT, 6 more patients will added to this for a total of 9 evaluable patients. If 1/3 initial patients have a DLT, then 3 more patients will be accrued in cohort III. If 1/6 patients have a DLT, then this arm will be considered safe, and 3 further patients will be accrued. Patient's vital signs will be monitored for one hour following each vaccination, The three cohorts will be accrued sequentially. Cohort I will be accrued directly. Cohort II will begin accrual when at least one patient in cohort I has received all 5 vaccinations. Cohort III will begin accrual after 6 patients in cohort II have received all 5 vaccinations with no more than one DLT observed (this criterion has already been met in the study).


Criteria:

Inclusion Criteria: - Patients must have histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen. - Patients must be in second or third complete clinical remission. Stable complete clinical remission is defined as a) Stable CA125 < 35U/ml, (defined as CA125 that has not doubled from the post chemotherapy nadir, b) unremarkable physical examination, and c) no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis, may not be considered definite evidence of disease. - Expected survival of at least 4 months. - Karnofsky performance scale ≥70%. - Laboratory values within the following limits: - Hemoglobin > 10.0 g/dL - Neutrophil count > 1.5 x l09/L - Platelet count > 80 x l09/L - Serum creatinine < 2.0 mg/dL - Serum bilirubin < 2.5 x upper limit of institutional normal - AST/ALT < 2.5 x upper limit of institutional normal - Age ≥ 18 years. - Patient is > 4 weeks from completion of prior cytotoxic chemotherapy. - Able and willing to give valid written informed consent Exclusion Criteria: - Clinically significant heart disease (NYHA Class III or IV). - Patients with serious intercurrent illness, e.g., serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization. - Patients with a positive stool guaiac excluding hemorrhoids. - Patients with known autoimmune disease (ie rheumatoid arthritis, ulcerative colitis etc); or immune deficiency (HIV, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or those receiving immunosuppressive drugs such as systemic corticosteroids or cyclosporin, etc). - Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ. - History of previous severe allergic reactions to vaccines or unknown allergens. - Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. - Lack of availability for immunological and clinical follow-up assessments. - Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent. - Pregnancy or breast-feeding. - Women of childbearing potential: Refusal or inability to use effective means of contraception.


NCT ID:

NCT00616941


Primary Contact:

Principal Investigator
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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